Standards

Instead of reinventing the wheel, I thought I would bring this question to my friends and mentors here.


I'm trying to develop a matrix that aligns ISO 9001:2015 clauses/requirements with typically used standard quality tools to meet that requirement. I am just trying to put together something that top management can use as a starting point for demonstrating leadership and  commitment with respect to the QMS as described in clause 5.1.1. 


Any ideas or lists from ASQ members are welcome as they will improve this brainstorming session. 


Thank you in advance.

Interesting question.  I'll get it started and others can add to it.  Here's a list of the sections of ISO 9001, and some tools typically used.  Not all are necessarily considered "quality" tools, but anything that can help in designing, managing, reviewing, improving processes ...

4.  Stakeholder analysis, SWOT analysis
5.  Skip-level meetings
6.  Bowtie, X-matrix
7.  Scorecards/dashboards, e-QMS
8.2  Focus groups
8.3  FMEAs, validation testing
8.4  Surveys, audits
8.5  Mistake proofing, SPC
9.  Surveys, audits
10.  RCA, Seven QC tools, Seven Management tools
All way thru: Metrics

 

Some additions:

8.3  MSA, Cpk

8.5  Control plans

 

Dear Amanda Foster,


I wrote this for ISO 17025 to address risk. You might want to take a look. http://www.metavisualdata.com/risk.html


The matrix can be changed with changes in the number. Risk treatment example also given :)


Yours sincerely,

Ernest

Thank you Duke Okes‍ and Ernest Phoon‍, these are great suggestions. I appreciate the input and will compare these to the work I've done so far.